BR Waterfull BB BLEMISH BALM NATURAL by BRcosmetic

BR Waterfull BB BLEMISH BALM NATURAL by

Drug Labeling and Warnings

BR Waterfull BB BLEMISH BALM NATURAL by is a Otc medication manufactured, distributed, or labeled by BRcosmetic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BR WATERFULL BB BLEMISH BALM NATURAL- titanium dioxide, octinoxate cream 
BRcosmetic

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

Titanium Dioxide 7.0%, Ethylhexyl Methoxycinnamate 1.5%

INACTIVE INGREDIENTS

Water, Caprylic/Capric Triglyceride, Glycerin, Propylene Glycol, Petrolatum, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl PEG/PPG-10/1Dimethicone, Dimethicone, Beeswax, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Trehalose, Panthenol, Sodium hyaluronate, Sodium Chloride, Sorbitan Sesquioleate, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Caprylhydroxamic Acid, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Triethoxycaprylylsilane, Talc, BHT, Disodium EDTA, Fragrance

PURPOSE

Sunscreen

WARNINGS

1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

DESCRIPTION

Indications & Usage: 1. Shake before using, apply evenly to clean face after skin care and treatment serum. 2. Tap applied face softly for better absorption. 3. Always replace cap after use

Dosage & Administration: Apply appropriate amount onto face after applying activator or cleansing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BR WATERFULL BB BLEMISH BALM NATURAL 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81345-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.8 g  in 40 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.6 g  in 40 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)	Â
Glycerin (UNII: PDC6A3C0OX)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81345-020-01	40 g in 1 CARTON; Type 0: Not a Combination Product	12/01/2020	01/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2020	01/30/2021

Labeler - BRcosmetic (695596476)

Registrant - BRcosmetic (695596476)

Establishment
Name	Address	ID/FEI	Business Operations
BRcosmetic		695596476	manufacture(81345-020)

Revised: 6/2021

Document Id: f5b261e1-8a05-4b7c-a772-3a737d8b29a0

34390-5

Set id: 04c9af82-d206-499a-a221-3d46d0430438

Version: 2

Effective Time: 20210617

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